Job Title: Senior Engineer, Quality Assurance Engineering - Individual ContributorJob Description As a Senior Engineer in Quality Assurance Engineering, you will play a crucial role in ensuring the quality performance of products and processes. You will work closely with operations and business functions to address quality issues, manage non-conformances, and drive process improvements. Your expertise will be critical in collaborating with suppliers and supporting manufacturing transfers, as well as engaging in process validation and improvements. Responsibilities + Work closely with operations and business functions to ensure quality performance of products and processes. + Collaborate with internal cross-functional and supplier teams to address quality issues. + Own and manage internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA) using Trackwise. + Support execution and analysis of manufacturing-related complaint investigations and product field actions. + Investigate and manage disposition of internal non-conforming products within MRB, issuing NCs as needed. + Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as necessary. + Execute and manage Supplier Initiated Change Requests (SICRs), engaging with cross-functional teams for assessment and approval. + Support manufacturing transfers to/from other plants/facilities with appropriate quality activities. + Collaborate with stakeholders to identify and execute supplier part certification opportunities. + Engage in the development and improvement of internal manufacturing and distribution processes for existing products. + Perform critical assessments and qualifications of change management activities, including PPAP activities for supplier changes. + Participate in and potentially lead the creation and review of new or modified procedures. + Support the development and review of process and equipment validation/qualification and MSA of internal processes. + Maintain KPIs for monitoring process and product quality, perform analysis, and interpret trends, taking appropriate actions as necessary. + Perform other related duties as assigned. Essential Skills + Minimum of 3 years of experience in quality assurance or related field. + BA Degree in Science/Technical field or related field. + Experience in CAPA and using Trackwise/ERP systems. + Proficiency in MS Suite. + Strong multi-tasking, communication, and problem-solving skills. Additional Skills & Qualifications + Power BI knowledge is a plus but not required. + CQE and/or LSSGB certification is beneficial. + Previous medical device industry experience is desired with understanding of US and International Medical Device Regulations. + Familiarity with GDP, GMP, and experience interacting with regulatory agencies such as FDA and TUV. + Knowledge of key quality concepts such as Risk Management, CAPA, Audits, and Statistics. + Project management, leadership, and influencing skills. + Ability to manage multiple tasks simultaneously and complete projects in a matrix organization. + Strong interpersonal, written, and oral communication skills. + Highly-developed critical, problem-solving, and analytical skills. + Ability to work in a fast-paced, dynamic, and time-critical manufacturing environment. Work Environment The position supports the 2nd shift from 3:30 pm to 2:00 am, Monday through Thursday. The work environment is dynamic and fast-paced, requiring the ability to adapt quickly and efficiently to changing circumstances. Job Type & Location This is a Contract position based out of Redmond, Washington. Pay and Benefits The pay range for this position is $70.00 - $80.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Redmond,WA. Application Deadline This position is anticipated to close on Sep 4, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.